Erector Spinae Block -Dexmedetomidine (esp -dex)

February 16, 2024 updated by: ferdi gülaştı, Aydin Adnan Menderes University

Comparison of the Effects of Remifentanil and Dexmedetomidine on Postoperative Acute Pain in Patients Who Received Erector Spina Plane Block in Spinal Surgeries

Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.

Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

investigators propose a randomized double-blind study comparing the use of intraoperative dexmedetomidine (Group D) for analgesic purposes with the use of intraoperative remifentanil (Group R) in patients undergoing ESP block for spinal surgery.

The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with.

Group 1: Dexmedetomidine infusion will be administered for intraoperative analgesia Group 2: Remifentanil infusion will be administered for intraoperative analgesia Routine anesthesia protocol in our clinic: patient is induced with fentanyl 1μg/kg IV and propofol 1.5 to 2 mg/kg IV, rocuronium 0.6 mg/kg IV. After putting the patients to sleep, ESP block is applied to the patients for postoperative pain management.

The peroperative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol was determined as 1 g and tramadol was determined as 1 mg/kg. Then it is paracetamol every eight hours and tramadol from PCA.

At the end of the operation, patients' pain levels will be determined and recorded with the Numeric Rating Scale (NRS) system at 4-hour intervals in the first 24 hours postoperatively.

Demographic data to be obtained will include height (cm), weight (kg), age (years), gender, physical condition (ASA) and specific procedure type will be recorded. Patients will be asked about tobacco, alcohol use and drug use. They will also be asked about their medical history, including lung disease, kidney disease, diabetes mellitus, neurological disease, chronic pain conditions, previous surgery or stent placement, and medications. Current preoperative laboratory tests and medication list will be recorded. Preoperative pain scores, NRS, and opioid use will be recorded. Pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system during the first 24 hours postoperatively. Additionally, opioid consumption will be evaluated from the PCA device used postoperatively. Patients excluded for any reason, including technical considerations or contraindications, will be enrolled.

How much intraoperative bleeding occurred, how much blood and blood products were transfused to the patient, and the duration of surgery will be recorded.

F. DATA ANALYSIS Statistical analyzes will be performed using SPSS. Before statistical testing, each continuous variable will be analyzed using the Kolmogorov-Smirnov test to determine whether it has a normal distribution. Continuous data are described as mean (SD) or median (25% and 75% percentiles) and will be analyzed by independent t test or Mann-Whitney U test, respectively. Categorical data were described as frequency or percentage and will be analyzed using the chi-square test. One-way ANOVA with multiple comparison test will be used for comparison between groups. For periods between first PCA triggers, data will be analyzed using the Kaplan-Meier survival method and compare groups using the log-rank test. Results will be expressed as mean ± SD or absolute number, and a P value < 0.05 will be considered statistically significant.

G. NUMBER OF SAMPLES Shobana Rajan et al. Based on their study, investigators calculated a sample size of 37 patients per group by setting alfa equal to 0.005 and beta equal to 0.8.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent;
  • 18-75 years old
  • ASA Physical Status 1-3;
  • Patients planned for lumbar disc surgery

Exclusion Criteria:

  • Rejection during registration
  • Request for dismissal from employment
  • Inability to give informed consent
  • Emergency surgery
  • Bleeding diathesis
  • Chronic use of opioids
  • Psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group 1
Dexmedetomidine (dekstomid) infusion will be administered for intraoperative analgesia.
Drug: esp Dexmedetomidine (dekstomid)
After anesthesia and surgical procedures, bilateral ESP block will be applied under ultrasonography guidance from the midline 3 cm lateral from the T10 level. After cleaning the area with povidone-iodine before the block, the T10 transverse protrusion will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection with physiological saline without local anesthesia. After the location of the needle is confirmed, 20 ml of LA and saline mixture will be applied and the same process will be repeated in the contralateral side. Of the total 40 ml LA, 20 ml will consist of bupivacaine 0.5% (marcaine), 10 ml will consist of lidocaine 2% (aritmal), and 10 ml will consist of physiological saline.
Other: group 2
remifentanyl (ultiva) infusion will be administered for intraoperative analgesia.
Drug: esp remifentanyl (ultiva)
After anesthesia and surgical procedures, bilateral ESP block will be applied under ultrasonography guidance from the midline 3 cm lateral from the T10 level. After cleaning the area with povidone-iodine before the block, the T10 transverse protrusion will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection with physiological saline without local anesthesia. After the location of the needle is confirmed, 20 ml of LA and saline mixture will be applied and the same process will be repeated in the contralateral side. Of the total 40 ml LA, 20 ml will consist of bupivacaine 0.5% (marcaine), 10 ml will consist of lidocaine 2% (aritmal), and 10 ml will consist of physiological saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: 24 hours
Patients' opioid consumption on the PCA device will be recorded at 0, 3, 6, 12, 18, and 24 hours postoperatively.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Numeric Rating Scale (NRS)
Time Frame: 24 hours
Preoperative period and Postoperative 30th minute, 1st, 6th, 12th, 18th. And at the 24th hour, patients' pain levels and NRS scores will be recorded. At the end of the operation, patients' pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system at intervals in the first 24 hours postoperatively. NRS; It is a pain intensity determination system based on the system of having the person say a point between 0 (no pain), 10 (unbearable pain) and 10 (unbearable pain) to describe his/her pain.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: ferdi gülasştı, Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-12-23/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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